THE FRENCH REPUBLIC Ministry of Ecological Transition Ministry of Solidarity and Health

Draft Order of

laying down the list of substances with endocrine disrupting properties referred to in I and II of Article L. 5232-5 of the Public Health Code and the categories of products presenting a particular risk of exposure referred to in Article L. 5232-5 of the Public Health Code

NOR:

Persons concerned: Any person who places on the market products for consumers which, at the end of their manufacture, contain substances which the French Agency for Food, Environmental and Occupational Health & Safety (ANSES) qualifies as having verified, presumed or suspected endocrine disrupting properties

Order of 28 September 2023 laying down the list of substances with endocrine disrupting
properties referred to in I and II of Article L. 5232-5 of the Public Health Code and the categories of
products presenting a particular risk of exposure referred to in Article L. 5232-5 of the Public
Health Code
NOR: TREP2323345A
ELI: https://www.legifrance.gouv.fr/eli/arrete/2023/9/28/TREP2323345A/jo/texte
JORF No 0237 of 12 October 2023
Text No 13
 Annex
 Annex
Persons concerned: any person who places on the market products for consumers which, at the end
of their manufacture, contain substances which the French Agency for Food, Environmental and
Occupational Health & Safety (ANSES) classifies as having verified, presumed or suspected endocrine
disrupting properties.
Purpose: This Order identifies:

substances with endocrine disrupting properties classified as verified and presumed, referred to in Article L. 5232-5 of the Public Health Code, including the information on the presence in the products referred to in Article R. 5232-19 of the Public Health Code must be made available to the public by the persons who place them on the market;

substances with endocrine disrupting properties classified as suspected, referred to in Article L. 5232-5 II of the Public Health Code;

categories of products with a particular risk of exposure to which the obligation to provide information on the presence of endocrine disrupting substances classified as suspected applies.

Entry into force: The text shall enter into force on 1 January 2022.

Notice: Article 13-II of Law No 2020-105 of 10 February 2020 on combating waste and the circular economy, so-called ‘AGEC’, provides that any person placing products on the market for consumers containing substances for which the French Agency for Food, Environmental and Occupational Health & Safety (ANSES) classifies the endocrine disrupting properties as verified or suspected must “provide information to the public by electronic means, in an open, easily reusable and exploitable format by an automated processing system, for each of the products concerned, to identify the presence of such substances in those products”. This obligation also applies to certain categories of products with a particular risk of exposure, for substances which endocrine disrupting properties are suspected by ANSES.

This obligation is in line with the objectives of the Second National Endocrine Disruptors Strategy (NSPE2). It aims to provide citizens with transparent information on the presence of substances with endocrine disrupting properties in products, in the sense of substances, mixtures, articles and foodstuffs.

The detailed rules for the application of this legislative provision have been laid down in Articles R. 5232-19 to R. 5232-22 of the Public Health Code. Article R. 5232-19 provides that a joint order of the ministers responsible for health and the environment sets out, on a proposal from ANSES:

the list of substances with endocrine disrupting properties referred to in I of Article L. 5232-5, divided into two categories, verified and presumed, according to the level of scientific evidence;

substances with endocrine disrupting properties classified as verified and presumed, referred to in
Article L. 5232-5 of the Public Health Code, including the information on the presence in the products
referred to in Article R. 5232-19 of the Public Health Code must be made available to the public by
the persons who place them on the market;
substances with endocrine disrupting properties classified as suspected, referred to in Article L. 5232-
5 II of the Public Health Code;
categories of products with a particular risk of exposure to which the obligation to provide
information on the presence of endocrine disrupting substances classified as suspected applies.
Entry into force: the text shall enter into force on the day after its publication.
Notice: Article 13-II of Law No 2020-105 of 10 February 2020 on combating waste and the circular
economy, so-called ‘AGEC’, provides that any person placing products on the market for consumers
containing substances for which the French Agency for Food, Environmental and Occupational Health
& Safety (ANSES) classifies the endocrine disrupting properties as verified or suspected must “provide
information to the public by electronic means, in an open, easily reusable and exploitable format by
an automated processing system, for each of the products concerned, to identify the presence of
such substances in those products”. This obligation also applies to certain categories of products with
a particular risk of exposure, for substances which endocrine disrupting properties are suspected by
ANSES.
This obligation is in line with the objectives of the Second National Endocrine Disruptors Strategy
(NSPE2). It aims to provide citizens with transparent information on the presence of substances with
endocrine disrupting properties in products, in the sense of substances, mixtures, articles and
foodstuffs.
The detailed rules for the application of this legislative provision have been laid down in Articles R.
5232-19 to R. 5232-22 of the Public Health Code. Article R. 5232-19 provides that a joint order of the
ministers responsible for health and the environment sets out, on a proposal from ANSES:
the list of substances with endocrine disrupting properties referred to in I of Article L. 5232-5, divided
into two categories, verified and presumed, according to the level of scientific evidence;
the list of substances with suspected endocrine disrupting properties referred to in Article L. 5232-5;

the categories of products presenting a particular risk of exposure referred to in II of Article L. 5232-5, with regard to the exposed populations, the conditions of use and disposal of those products and other relevant criteria.

References: the text can be found on the Légifrance website (http://legifrance.gouv.fr).

The Minister for Ecological Transition and the Minister for Solidarity and Health

Having regard to Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC

Having regard to Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC

Having regard to Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products

Having regard to the Public Health Code, in particular Article L. 5232-5 in its wording resulting from Article 13 of Law No 2020-105 of 10 February 2020 on combating waste and the circular economy and Article R. 5232-19 thereof;

Having regard to the opinion of the French Agency for Food, Environmental and Occupational Health & Safety issued on XXXX;

the categories of products presenting a particular risk of exposure referred to in II of Article L. 5232-
5, with regard to the exposed populations, the conditions of use and disposal of those products and
other relevant criteria.
For certain substances, due to their nutritional character (vitamins, minerals) and their health
benefits up to a certain dose (higher safety limits), such as cholecalciferol (vitamin D3), the
information on the presence of substances with endocrine disrupting properties will be adapted to
indicate that these substances present health benefits according to the precautions for use and
dosage specified on the package leaflet or labelling of the product and that in case of doubt the
advice of a health professional should be sought. This specific information is provided for by the
Order specifying the detailed rules relating to the content and the conditions for the presentation of
the information provided for in I and II of Article L. 5232-5 of the Public Health Code. The substances
covered by this specific information are listed in Tables Aa and Ba in the Annex to this Order.
References: the text can be found on the Légifrance website (https://legifrance.gouv.fr).
The Minister for Ecological Transition and Territorial Cohesion and the Minister for Health and
Prevention,
Having regard to Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18
December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals
(REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing
Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council
Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and
2000/21/EC
Having regard to Regulation (EC) No 1107/2009 of the European Parliament and of the Council of
21 October 2009 concerning the placing of plant protection products on the market and repealing
Council Directives 79/117/EEC and 91/414/EEC
Having regard to Regulation (EU) No 528/2012 of the European Parliament and of the Council of
22 May 2012 concerning the making available on the market and use of biocidal products
Having regard to Directive (EU) 2015/1535 of the European Parliament and of the Council of
9 September 2015 laying down a procedure for the provision of information in the field of technical
regulations and of rules on Information Society services, and in particular Notification
No 2021/0680/F;
Having regard to the Public Health Code, in particular Article L. 5232-5 in its wording resulting from
Article 13 of Law No 2020-105 of 10 February 2020 on combating waste and the circular economy
and Article R. 5232-19 thereof;
Having regard to the opinions of the French Agency for Food, Environmental and Occupational
Health & Safety issued on 25 March 2021 and 29 September 2022,
Hereby decree:

Article 1

Substances with verified and presumed endocrine disrupting properties referred to in I of Article L. 5232-5 of the Public Health Code are listed in Table A in Annex I to this Order.

Article 1
Substances with verified and presumed endocrine disrupting properties referred to in I of Article L.
5232-5 of the Public Health Code are listed in Tables A and Aa in Annex I to this Order.
Article 2

Substances with suspected endocrine disrupting properties referred to in Article L. 5232-5 II of the Public Health Code are listed in Table B in Annex I to this Order.
Substances with suspected endocrine disrupting properties referred to in Article L. 5232-5 II of the
Public Health Code are listed in Tables B and Ba in Annex I to this Order.

Article 3

The categories of products presenting a particular risk of exposure referred to in Article L. 5232-5 II of the Public Health Code are listed in Annex II to this Order.

The categories of products presenting a particular risk of exposure referred to in Article L. 5232-5 II of
the Public Health Code are listed in Annex II to this Order.
Article 4

The provisions of this Order shall enter into force on 1 January 2022.

The provisions of this Order shall enter into force on the day following the publication of this Order.
Article 5

This Order shall be published in the Official Journal of the French Republic.

Made on [date]

The Minister for the Ecological Transition,

The Director-General for Risk Prevention and the Director-General for Health are responsible, each
one as far as they are concerned, for the implementation of this Order, which shall be published in
the Official Journal of the French Republic.
Annex
Annexes
ANNEX I
LIST OF SUBSTANCES WITH ENDOCRINE DISRUPTING PROPERTIES REFERRED TO IN I AND II OF
ARTICLE L. 5232-5 OF THE PUBLIC HEALTH CODE
TABLE A
List of substances with verified and presumed endocrine disrupting properties referred to in Article L.
5232-5 of the Public Health Code
Substance included in
the Candidate List of
Substances of Very
High Concern for
Authorisation
(published on the
CE CAS
Substance name website of the
number number
European Chemicals
Agency pursuant to
Article 59(10) of the
above-mentioned
Regulation (EC) No
1907/2006 (REACH))
224- 4247-02-
Isobutyl 4-hydroxybenzoate yes
208-8 3
4,4'-sulphonyldiphenol 201- 80-09-1 yes

250-5
(±)-1,7,7-trimethyl-3-[(4-
methylphenyl)methylene]bicyclo[2.2.1]heptan-2-one
- - yes
covering any of the individual isomers and/or
combinations thereof (4-MBC)
(±)-1,7,7-trimethyl-3-[(4- 253- 36861-
yes
methylphenyl)methylene]bicyclo[2.2.1]heptan-2-one 242-6 47-9
(3E)-1,7,7-trimethyl-3-(4- 1782069-
- yes
methylbenzylidene)bicyclo[2.2.1]heptan-2-one 81-1
(1R,3E,4S)-1,7,7-trimethyl-3-(4- 95342-